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CDASH (Clinical Data Acquisition Standards Harmonization) is the CDISC standard for how data is collected on case report forms (CRFs) in clinical trials. CDISC describes it as establishing “a standard way to collect data consistently across studies and sponsors.” It is published by the Clinical Data Interchange Standards Consortium (CDISC), and it is built so that collected data can be traced into the Study Data Tabulation Model (SDTM). Not to be confused with CDash, the Kitware software-testing dashboard that shares the name.
What it is
CDASH gives study teams a common set of data collection variables and form conventions, so that each trial does not invent its own CRF questions and variable names. It sits at the front of the CDISC data flow: CDASH covers collection, SDTM covers tabulation of submission data, and ADaM covers analysis datasets (see CDISC SDTM vs ADaM).
The CDASH Implementation Guide (CDASHIG) is the document teams work from. According to CDISC, CDASHIG metadata uses the same observation classes and domains as the SDTM Implementation Guide, which supports traceability and some automation of SDTM dataset creation. The current version listed by CDISC when this page was checked is CDASHIG v2.3 (28 September 2023), which aligns with SDTMIG v3.3 and v3.4 and relates to CDASH Model v1.3 and the CDASH SAE Supplement v2.0. Each CDASH model release builds on the previous one and is backward compatible.
Who runs it and what it covers
CDASH is developed and published by CDISC, a non-profit standards organization. The CDASHIG metadata tables detail the data collection variables within each domain; the full tables are held in the CDISC Library and require sign-in. Teams designing protocols under Good Clinical Practice use such standards to keep collected data consistent and traceable.
How to use it
Teams generally start from the approved clinical trial protocol design, choose the CDASHIG domains that match what the protocol collects, build the forms in an electronic data capture (EDC) system using the CDASH variables and prompts, and check that collected data maps cleanly to SDTM. For the wider data-handling context see clinical data management and CDISC clinical data standards.
Strengths and limits
Strengths
- Consistency: collecting data the same way across studies and sponsors, as CDISC states.
- Traceability: collected data can be traced into SDTM.
Limits
- Adoption effort: moving existing CRF libraries and templates to a new standard takes work.
- Collection versus tabulation: CDASH is a collection standard and does not replace SDTM or ADaM.
Alternatives and related standards
| Standard | Governing body | Role |
|---|---|---|
| CDASH | CDISC | Data collection variables and CRF conventions |
| SDTM | CDISC | Tabulation of study data for submission |
| ADaM | CDISC | Analysis datasets |
FAQ
What does CDASH stand for?
Clinical Data Acquisition Standards Harmonization.
What is CDASH CDISC?
“CDASH CDISC” refers to the same thing: the CDASH standard published by CDISC for collecting clinical trial data consistently.
How does CDASH differ from SDTM?
CDASH is about how data is collected on the form. SDTM is about how data is tabulated for submission. CDASH is designed so collected data can be traced into SDTM.
Does FDA require CDASH?
The FDA pages checked for this guide list SDTM among the formats for study data submissions but do not mention CDASH, so this guide makes no claim that CDASH is required or recommended by FDA. Check the FDA Data Standards Catalog for current requirements.
Sources
- CDISC, CDASH: https://www.cdisc.org/standards/foundational/cdash (checked 2026-11-07)
- CDISC, CDASHIG v2.3: https://www.cdisc.org/standards/foundational/cdash/cdashig-v2-3 (checked 2026-11-07)
- U.S. FDA, Study Data Standards Resources: https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources (checked 2026-11-07)
